For authors affiliations and current authors addresses, see end of text.
Acknowledgments: The authors thank the staff members of their student health services, their own research nurses and staff members, and Wendy Tennant of Boehringer Ingelheim Pharmaceuticals, Inc.
Grant Support: In part by grants from Boehringer Ingelheim Pharmaceuticals, Inc.
Requests for Reprints: Frederick G. Hayden, MD, Box 473, Department of Internal Medicine, University of Virginia Health Sciences Center, Charlottesville, VA 22908.
Current Author Addresses: Dr. Hayden: Department of Internal Medicine, University of Virginia School of Medicine, Box 473, Charlottesville, VA 22908.

Abstract

To determine the tolerability and clinical effectiveness of intranasal ipratropium bromide for the treatment of symptoms of common colds.

Design:

Multicenter, double-blind, randomized trial.

Setting:

3 university student health services.

Patients:

411 previously healthy persons 14 to 56 years of age who had cold symptoms that had lasted for no more than 36 hours, rhinorrhea subjectively judged to be of at least moderate severity, and documented nasal discharge of at least 1.5 g over a 1-hour observation period.

Intervention:

Either 1) ipratropium bromide nasal spray 0.06% in buffered salt solution, two 42-µg sprays per nostril administered by metered pump spray; 2) control nasal spray, which consisted of buffered salt solution; or 3) no treatment. Treatments were self-administered three or four times daily during waking hours for 4 days. After receiving their morning dose, patients stayed at the study center for 6 hours on study day 1 and 3 hours on study day 2; symptom severity was recorded and nasal mucus discharges were collected and weighed hourly during these periods.

Results:

Ipratropium recipients had 26% less nasal discharge than controls (P = 0.0024) and 34% less nasal discharge than untreated patients (P = 0.0001). Severity of rhinorrhea as judged subjectively was reduced in ipratropium recipients by 31% compared with controls and by 78% compared with untreated patients (P = 0.0001 for both comparisons). In addition to being associated with reductions in daily assessments of the severity of rhinorrhea (P < equals 0.003), ipratropium was associated with reduced sneezing on study days 2 (20% difference; P = 0.03) and 4 (30% difference; P = 0.02) but not with reduced nasal congestion compared with the control spray. Ipratropium was generally well tolerated but was associated with higher rates of blood-tinged mucus (16.8% in the ipratropium group compared with 3.6% in the control group; P = 0.01) and nasal dryness (11.7% in the ipratropium group compared with 3.6% in the control group; P = 0.021) than the control spray. Patient assessments of the overall effectiveness of treatment were more favorable for ipratropium than for the control spray (P < equals 0.026) or for no treatment (P < equals 0.002) on each day of inquiry (study days 1, 2, and 5).